QC Specialist

This role is a Fixed Term, 12-month Contract position based at our Brisbane site.

The Quality Control team in Brisbane supports clients' studies required for regulatory acceptance of their drug substance and drug product. Responsibilities include assuring timely, accurate and scientifically sound output of data from the Stability Studies, CoA/SoT generation for batch release, shipment of test samples, coordinating and accepting results from external third party test facilities, as required for each customer project.

The successful candidate will independently liaise with Clients and Project Managers regarding their Quality requirements for stability studies, batch testing, external shipments and external contract testing. Efficiently handle Client queries, expectations and challenges. Supply and update relevant information and results to Project Managers and clients.

Collaborate with QC Labs, QA, Program Management, Warehouse and Logistics, 3rd party contract labs, equipment/Maintenance vendors and contractors

Generate shipping documentation and sample submission forms required for testing of Client samples at external facilities. Review and approve test reports supplied from external facilities

Perform aseptic aliquoting of bulk samples (typically from the Operations department).

Support Quality Control laboratory teams as required to ensure relevant testing is performed on time and ensure accordance with Regulatory Guidelines, in performance and guidelines for Client stability studies

Knowledge of Change Control, Deviations, CAPA, OOS and OOT, Document Management, related to the Quality Systems operating on the Brisbane site.

Practical application of various risk assessments tools (i.e. failure mode effect analysis, fishbone diagrams, hazard and operability studies)

Engage with the Quality teams (QA and QC) to ensure batch release documentation and site delivery times are met in a profitable manner

Support PPI activities for the business

Ensure traceability and legibility of all QC documentation and ensure effective execution of documentation records for client requirements

Support generation and approval of Work Flows and MLPs in gLIMS

Work within EH&S guidelines, Corporate Quality Standards, Standard Operating Procedures and data integrity, maintain the Companies TGA and other manufacturing licenses

Mentor and motivate members of the team by delivering training of QC staff as required.

To be successful in this role you will need:

• Bachelor of Science (Bio-Technology, Chemistry, or closely related degree)
• At least 2 years industry work experience in the pharmaceutical or biotechnology industry aligned to Analytical and Quality Control fields
• Knowledgeable with test method development, qualification, validation
• Must be knowledgeable in cGMP practices and quality management systems (QMS) including experience with deviations, CAPA, OOS, OOT, document management, change control etc
• Enjoy working in a highly fast paced and frequently changing environment with a wide variety of people and perspectives
• Experience in stability studies suitable for the bio-pharmaceutical industry
• Good attention to detail as a team member and when working independently
• Can communicate in multiple modalities (e.g. electronic, written, verbal, etc.)
• Ability to prioritise multiple Client programs and reports simultaneously
• Understanding of Microsoft applications (e.g. Excel, Word, Outlook)
• Ability to use Smartsheets
• Knowledge of LIMs Sample Manager
• Adaptability: Ability to adapt to every day business requirements.
• Collaborating: Work constructively with all departments and colleagues of multicultural backgrounds.
• Continuous Improvement: Challenge current systems to drive process improvements.
• Customer Requirements: Always deliver on promises made to customers.
• Initiating Action: Work independently, and also show initiative in planned work. Ability to work on multiple projects or tasks simultaneously.
• Handling Relations: Demonstrates the ability to support customer demands within business requirements and agreed timelines.
• Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail and accurate completion of test records. Strives for right first time in every task undertaken.

We offer a competitive salary package and a range of benefits, including:

• Health & Wellbeing: Comprehensive benefits including company paid private health insurance and risk benefits insurance (via selected provider), wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
• Flexibility: Balance your work and personal life with flexible arrangements.
• Extra Leave: Benefit from generous leave policies, including option to purchase additional leave, paid birthday leave, and company paid parental leave.
• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

We are committed to building a diverse and inclusive workplace culture where everyone feels valued, respected, and supported. We welcome applicants from all backgrounds and encourage applications from women, Aboriginal and Torres Strait Islander peoples, people from culturally and linguistically diverse backgrounds, and people with disabilities.